A new harmonised regulation on health technology assessment has been adopted across the EU.
The European Commission welcomed the regulation, a deliverable of the EU Pharmaceutical Strategy, which will apply from January 2025.
Work to implement the new rules will start immediately, including the setting up of the necessary governance structure and preparatory documents to ensure effective...
The EU’s new regulation on medical devices finally came into full application today, following a year’s delay due to the COVID-19 pandemic.
According to the European Commission, the Medical Devices Regulation (MDR) seeks to ensure a high level of public health and patient safety taking into account scientific progress.
The regulation entered into force in May 2017, replacing the Medical Devices...
A service allowing national apps to talk to each other has been set up by the European Commission, allowing users to receive a warning if they were in contact with someone who has indicated that they have tested positive for COVID-19.
Adopted by the majority of the Member States, the service works according to a “decentralised” system where the calculations happen in the user’s app. In...
The GAIA-X initiative has designed a technical architecture that ensures trustworthy data exchange in Europe and forms the basis for a comprehensive data ecosystem.
With 300 organisations from various countries involved, the project has gained support from German and French governments, and has links to the European Commission.
Science institutions and representatives of the Federal Government...
Following months of regulatory investigation, the European Commission has officially signed off on Google's $2.1 billion purchase of health-wearable-maker Fitbit. Still, the go-ahead is contingent on a handful of commitments from the tech company that focus on its competitive practices across advertising, digital health APIs and smart device interoperability.
"We can approve the proposed...
Searching for outbreaks. The long and sometimes muddled tradition of predicting outbreak hot spots by analyzing search engine activity has continued into the COVID-19 era, with Mayo Clinic researchers publishing new findings that suggest strong correlations between certain keywords and case reports. In reviewing data from Jan. 22 to April 6, "face mask," "Lysol" and "COVID stimulus check" had the...
Leaders from across the health sector released a joint statement underlining the potential of the recently-published draft proposal for a European Partnership for Health Innovation, or Innovative Health Initiative (IHI), released by the European Commission.
The statement – which accounts for COCIR, EFPIA, EuropaBio, MedTech Europe and Vaccines Europe, all partners in the initiative – acknowledge...
The European Commission has adopted a recommendation to support exit strategies with a standardised approach to mobile data usage and apps development as some member states begin a slow relaxation of measures implemented in an effort to contain the coronavirus pandemic.
Digital tools are central to the recommendation, which is based on the adoption of a toolbox currently on schedule to be...
German startup secures funding. Berlin-based digital health startup mika has landed a seven-figure financing deal from venture capital firm Ananda Impact Ventures and VC Fonds Technologie Berlin, managed by the IBB investment company. The exact sum was not disclosed to the media.
The startup, founded in 2017 by Dr Gandolf Finke and Dr Jan Simon Raue, has developed an app to support cancer...
Governments, industry and regulators worldwide are trying to make the pharmaceutical supply chain more bullet-proof and the use of blockchain based track and trace technology has been hailed as a possible solution. Blockchain is an electronic cryptographic ledger which creates an immutable record of all events throughout the supply chain, allowing digital information to be distributed without...
